INCYTE

PrMINJUVITM has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization.

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MINJUVI™ (tafasitamab for injection) is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).1

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For healthcare professionals

MINJUVI™ Product Monograph

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Incyte Solutions™ Support Program Enrolment Form

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MINJUVI™ Core Visual Aid

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MINJUVI™ Dosage & Administration Brochure

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Safety information1

Clinical use:

Authorization was based on overall response rate, complete response rate and durability of response from a single-arm clinical study. An improvement in progression-free survival or overall survival has not been established.

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Geriatrics (≥65 years of age): Among 81 patients treated in the L-MIND study, 72% were 65 years and older. Patients 65 years of age and older had more serious treatment emergent adverse events (TEAEs) (57%) than younger patients (39%).

Evidence from clinical studies does not suggest that use in the geriatric population is associated with differences in effectiveness.

Contraindications:

  • MINJUVI™ is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most serious warnings and precautions:

Infection: Clinically significant and/or life-threatening adverse events including fatal, life-threatening, or serious infections, including opportunistic infections have been reported in patients treated with MINJUVI™ in combination with lenalidomide.

Myelosuppression: Serious and severe myelosuppression, including neutropenia, febrile neutropenia, thrombocytopenia, and anemia have been reported in patients treated with MINJUVI™ in combination with lenalidomide.

Progressive Multifocal Leukoencephalopathy (PML): PML can occur in patients receiving MINJUVI™ in combination with lenalidomide. MINJUVI™ treatment should be interrupted in case of PML suspicion, until the diagnosis can be clearly established. Discontinue MINJUVI™ therapy and consider discontinuation or reduction of lenalidomide therapy in patients who develop PML.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed in studies of MINJUVI™ in combination with lenalidomide. Patients should be screened for HBV infection before treatment initiation and should be monitored during and after treatment with MINJUVI™. In the event of HBV reactivation, MINJUVI™ should be discontinued.

Other relevant warnings and precautions:

  • MINJUVI™ is administered by intravenous infusion only. DO NOT administer as an intravenous push or bolus dose.
  • Infusion-related reactions may occur and have been reported in clinical studies with MINJUVI™.
  • Patients should be monitored closely throughout the infusion.
  • Patients should be monitored closely for tumor lysis syndrome during treatment. Patients with high tumor burden and rapidly proliferative tumor may be at increased risk of tumor lysis syndrome.
  • Vaccination with live vaccines is not recommended concurrently with MINJUVI™ therapy.
  • Treatment with tafasitamab in combination with lenalidomide should not be initiated in female patients unless pregnancy has been excluded.
  • MINJUVI™ may cause fetal harm. Advise females of reproductive potential to use effective contraception during MINJUVI™ treatment and for at least 3 months after the end of treatment.
  • MINJUVI™ is not recommended during pregnancy and in women of childbearing potential not using contraception.
  • Advise women not to breast-feed during treatment with MINJUVI™ until at least 3 months after the last dose.

For more information:

Please consult the Product Monograph here for important information relating to monitoring and laboratory tests, adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-833-309-2759 or contacting medinfocanada@incyte.com.

Reference: 1. MINJUVI™ Product Monograph. Incyte Corporation. August 19, 2021.